clinicaltrials.gov Identifier: NCT01448642.

No abstract

No abstract

Angio-Seal seems noninferior in the incidence of access site complications at 30 days when compared with the radial approach. © 2016 Wiley Periodicals, Inc.

Objectives To report clinical, angiographic characteristics, outcomes, and predictors of unsuccessful procedures in patients who underwent chronic total occlusion (CTO) percutaneous coronary interventions (PCI) in Latin America. Background CTO PCI has been increasingly performed worldwide, but there is a lack of information in this region. Methods An international multicenter registry was developed to collect data on CTO PCI performed in centers in Latin America. Patient, angiographic, procedural and outcome data were evaluated. Predictors of unsuccessful procedures were assessed by multivariable analysis. Results We have included data related to 1,040 CTO PCIs performed in seven countries in Latin America (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, and Puerto Rico). The mean age was 64 ± 10 years, and CTO PCI was performed mainly for angina control (81%) or treatment of a large ischemic area (30%). Overall technical success rate was 82.5%, and it was achieved with antegrade wire escalation in 81%, antegrade dissection/re‐entry in 8% and with retrograde techniques in 11% of the successful procedures. Multivariable analysis identified moderate/severe calcification, a blunt proximal cap and a previous attempt as independent predictors of unsuccessful procedures. In‐hospital major adverse cardiovascular events (MACE) occurred in 3.1% of the cases, death in 1% and cardiac tamponade in 0.9% Conclusions CTO PCI in Latin America has been performed mainly for ischemia relief. Procedures were associated with a success rate above 80% and low incidence of MACE. Predictors of unsuccessful procedures were similar to those previously reported in the literature.

No abstract

RESUMOIntrodução: A via de acesso femoral tem sido a preferida para os procedimentos diagnósticos e terapêuticos coronarianos, mas apresenta limitações, principalmente relacionadas a complicações vasculares e hemorrágicas. O acesso transradial é uma técnica mais recentemente empregada com o objetivo principal de diminuir essas complicações, além de produzir maior conforto e redução dos custos de hospitalização, embora com maior curva de aprendizagem. O objetivo deste estudo foi avaliar a realização de coronariografia transradial, executada por operadores sem experiência na técnica, e comparar com a abordagem clássica (Sones e femoral) em termos de sucesso do procedimento e complicações, analisando a influência da curva de aprendizagem. Método: Estudo multicêntrico realizado em 14 hospitais do interior de São Paulo, no período de um ano. Foram randomizados mil pacientes de maneira equivalente para as técnicas transradial ou clás-sica. Resultados: A taxa de sucesso em ambos os grupos foi similar (97,8% vs. 98,5%; P = 0,47). No grupo clássico, 95,2% dos procedimentos foram realizados pela técnica de Sones. O número de cateteres utilizados, a duração do procedimento e o tempo de exposição aos raios X foram maiores no grupo transradial (P < 0,001). Não houve diferença quanto às complicações maiores (morte, infarto e acidente vascular cerebral) e quanto às complicações vasculares e hemorrágicas. Os grupos que realizaram mais de 100 procedimentos pela artéria radial (3 centros/5 operadores) obtiveram menor taxa de insucesso (1,6% vs. 3,6%; P = 0,04). Conclusão: Um período de aprendizagem para a realização de procedimentos pela via transradial mostra-se necessário, porém não se acompanha de menor índice de sucesso, nem tampouco de maior taxa de complicações para os pacientes. DESCRITORES: Artéria radial. Angiografia coronária. Aprendizagem. ABSTRACT Transradial Coronary Angiography: Learning Curve, Evaluated by a Multicenter StudyBackground: Femoral access for diagnostic and therapeutic coronary procedures has been the dominant approach worldwide, despite an increased risk of vascular and hemorrhagic complications. The transradial approach is a more recent technique used to reduce these complications, providing more comfort and reducing hospitalization costs. However, it is associated with an inherent learning curve. The aim of the study was to evaluate transradial coronary angiography performed by inexperienced operators and compare the success and complication rates of this technique with the classical approach (Sones and femoral), analyzing the influence of the learning curve. Methods: Multicenter, randomized study, in 14 hospitals in São Paulo State in a one-year period. One thousand patients were randomized to the transradial or classical techniques. Results: The success rate was similar in both groups (97.8% vs. 98.5%; P = 0.47). Sones technique was used in 95.2% of the procedures in the classical technique group. The number of catheters used, the duration of the procedure and X-ray exposure were greater in the tr...

IMPORTANCE Loading doses of atorvastatin did not show reduction on clinical outcomes in the overall population of patients with acute coronary syndrome (ACS) enrolled in the Statins Evaluation in Coronary Procedures and Revascularization (SECURE-PCI) trial, but a potential benefit was identified in patients who subsequently underwent percutaneous coronary intervention (PCI). OBJECTIVES To determine whether periprocedural loading doses of atorvastatin are associated with decreased 30-day major adverse cardiovascular events (MACE) in patients with ACS undergoing PCI according to type of ACS and timing of atorvastatin administration before PCI. DESIGN, SETTING, AND PARTICIPANTS Secondary analysis of a multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites that enrolled 4191 patients with ACS intended to be treated with PCI between April 18, 2012, and October 06, 2017. INTERVENTIONS Patients were randomized to 2 loading doses of 80 mg of atorvastatin or matching placebo before and 24 hours after a planned PCI. By protocol, all patients (regardless of treatment group) received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. MAIN OUTCOMES AND MEASURES The primary outcome was MACE through 30 days, composed by all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization. Cox regression models adjusting for key baseline characteristics were used to assess the association between atorvastatin and MACE in patients undergoing PCI. RESULTS Fromtheoveralltrialpopulation,2710(64.7%)underwentPCI(650women[24.0%];mean [SD] age, 62 [11.3] years). Loading atorvastatin was associated with reduced MACE at 30 days by 28% in the PCI group (adjusted hazard ratio [HR], 0.72; 95% CI 0.54-0.97; P = .03). Loading dose of atorvastatinwasadministeredlessthan12hoursbeforePCIin2548patients(95.3%)(45.1% < 2hours and 54.3% between 2 and 12 hours). There was no significant interaction between treatment effect and timing of study drug administration. The treatment effect of loading atorvastatin was more pronounced in patients with ST-segment elevation myocardial infarction than in patients with non-ST-segment elevation ACS (adjusted HR, 0.59; 95% CI, 0.38-0.92; P = .02; HR, 0.85; 95% CI, 0.58-1.27; P = .43, respectively). CONCLUSIONS AND RELEVANCE In patients with ACS undergoing PCI, periprocedural loading doses of atorvastatin appeared to reduce the rate of MACE at 30 days, primarily in patients with ST-segment elevation myocardial infarction. This beneficial effect seemed to be preserved and consistent, regardless of timing of atorvastatin administration, including within 2 hours before PCI. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01448642